Restylane-L

GUDID 07331689113815

Q-Med AB

Dermal tissue reconstructive material, microbe-derived, anaesthetic

• Primary Device ID: 07331689113815
• NIH Device Record Key: 225c9fa5-9025-49bf-84a9-921c21a7b033
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restylane-L
• Version Model Number: Gel 1.0 ml syringe
• Company DUNS: 355371873
• Company Name: Q-Med AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331689113815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040024

FDA Product Code

• LMH: Implant, Dermal, For Aesthetic Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-13

On-Brand Devices [Restylane-L]

• 07331689113822: Gel 1.0 ml syringe - demo
• 07331689113815: Gel 1.0 ml syringe
• 07331689113792: Gel 0.5 ml syringe
• 07331689111774: Gel 2.0 ml syringe - demo
• 07331689111767: Gel 2.0 ml syringe
• 07331689111750: Gel 1.0 ml syringe - demo
• 07331689111743: Gel 1.0 ml syringe
• 07331689111736: Gel 0.5 ml syringe
• 00302995967161: Gel 1.0 ml syringe - demo
• 00302995967154: Gel 1 mL Syringe
• 00302995967147: Gel 1.0 ml syringe - demo
• 00302995967079: Gel 1 mL Syringe